Distinguished DMPK Scientist - Drug Metabolism PK Strategy

Merck & Co.; Rahway (NJ); Hybrid; USD 210,000 - 331,000; Full time

Job summary

Merck & Co. in the United States seeks a Distinguished Scientist to serve as a DMPK submission expert, leading nonclinical PK strategies to ensure robust filings from FIH to post-approval extensions.

The successful candidate will influence regulatory strategy, contribute to global filings, and help shape portfolio decisions with cross-functional teams. Strong leadership, negotiation skills, and enterprise mindset are essential.

Qualifications

• 15+ years in DMPK with leadership in drug discovery and development programs
• Strong understanding of regulatory guidelines and successful support of clinical candidates and FIH
• Experience mentoring program team representatives on nonclinical and clinical issues
• Proven ability to influence strategic direction across disciplines and functions
• Excellent written and verbal communication for clear regulatory documentation and presentations
• Experience authoring and reviewing nonclinical PK packages and regulatory sections (IBs, INDs, NDAs, etc.)
• Experience navigating regulatory requirements across modalities from preclinical through post-approval

Responsibilities

• Monitor late-stage development programs and ensure nonclinical packages align with filing strategy
• Represent PDMB in Label Approval Strategy Teams and regulatory discussions
• Review investigator brochures, INDs, NDAs, regulatory responses to support trials and registrations
• Provide scientific oversight for development candidates across therapeutic areas and modalities
• Contribute to Clinical Pharmacology strategy including starting dose and dose escalation considerations
• Ensure DMPK data and documentation meet regulatory expectations
• Lead internal initiatives to improve policies and regulatory guidance
• Oversee due diligence for in-licensing assets and integration of programs
• Develop future leaders in drug development and regulatory science

Skills

Drug Development

Drug Metabolism

Pharmacokinetics

Portfolio Strategies

Regulatory Filings

Regulatory Strategies

Regulatory Submissions

Scientific Leadership

Small Molecules

Education

PhD or MSci in Pharmaceutical Sciences, Pharmacology or related field

Job description

Merck & Co. in the United States seeks a Distinguished Scientist to serve as a DMPK submission expert, leading nonclinical PK strategies to ensure robust filings from FIH to post-approval extensions.

The successful candidate will influence regulatory strategy, contribute to global filings, and help shape portfolio decisions with cross-functional teams. Strong leadership, negotiation skills, and enterprise mindset are essential.